Regulatory Scientist

Regulatory Scientist - India - Office or Home ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development. We are currently seeking a Regulatory Scientist to join our diverse and dynamic team. In this role, you will support regulatory submissions for clinical trials in India and ensure alignment with applicable regulatory frameworks, contributing to the advancement of innovative therapies in partnership with leading pharmaceutical and biotech organizations. What you will be doing • Supporting and executing regulatory submissions for phases 1 to 3 clinical trials in India• Preparing and reviewing CT04, CT16 and related application documents through the SUGAM portal and ensuring accurate CTRI registrations• Managing documentation and archival systems including TMF, CTMS and Veeva Vault• Ensuring compliance with ICH GCP guidelines and India regulatory framework including NDCT 2019• Collaborating across internal stakeholder groups including DI, AI and ADCI to drive submission readiness• Monitoring regulatory updates including toxicity requirements and other evolving guidelines• Contributing to successful regulatory milestones through proactive planning and communication Your profile • Bachelor’s or master’s degree in a scientific or healthcare discipline• 4+ years of regulatory affairs experience, preferably within a CRO environment• Strong knowledge of CDSCO regulatory submission processes including SUGAM and CTRI portals• Familiarity with TMF, CTMS, Veeva Vault and electronic document management systems• Understanding of ICH GCP and India clinical trial regulations including NDCT 2019• Strong attention to detail and communication skills with the ability to manage timelines and priorities #LI-KT1 What ICON can offer you: Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs. Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead. Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being. Life assurance Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others. Visit our careers site to read more about the benefits ICON offers. At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles. Are you a current ICON Employee? Please click here to apply